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First-line Treatment with RC48 Plus Tislelizumab and S-1(RCTS) in Advanced Gastric Cancer

NCT05586061 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-02-07

No results posted yet for this study

Summary

This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Disitamab Vedotin in Combination With Tirelizumab and S-1 as first-line treatment for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Conditions

  • HER2-positive Gastric Cancer

Interventions

DRUG

Disitamab vedotin

Disitamab Vedotin: 2.5mg/kg, d1, ivdrip, (every 3 weeks) Q3W

DRUG

Tislelizumab

Tislelizumab: 200mg, d1, ivdrip, (every 3 weeks) Q3W

DRUG

S1

S-1: 40-60mg (according to patients' body surface area), po, bid, d1-14, discontinued for 7 days.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Lian Liu, Doctor · Qilu Hospital of Shandong University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-10
Primary Completion
2024-12-29
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05586061 on ClinicalTrials.gov